Alteplase

Alteplase is used for:

Restoring function to central venous access devices that have become clogged with clotted blood. It may also be used for other conditions as determined by your doctor.

Alteplase is a tissue plasminogen activator (tPA). It works by helping to break down unwanted blood clots.

Do NOT use Alteplase if:

• you are allergic to any ingredient in Alteplase

Contact your doctor or health care provider right away if any of these apply to you.

Before using Alteplase :

Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have active internal bleeding
• if you have had any type of surgery or medical procedure or have undergone childbirth within the past 48 hours
• if you have blood problems (eg, thrombocytopenia, blood clotting problems) or severe liver or kidney disease
• if you have an increased risk for complications due to clotting (eg, blood clot near the catheter)
• if you have a known or suspected infection at the catheter site

Some MEDICINES MAY INTERACT with Alteplase . Tell your health care provider if you are taking any of the following medicines.

• Abciximab, anticoagulants (eg, warfarin, heparin), aspirin, or dipyridamole because the risk of serious side effects, such as bleeding, may be increased
• Nitrates (eg, nitroglycerin, isosorbide dinitrate) because the effectiveness of Alteplase may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Alteplase may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Alteplase :

Use Alteplase as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Alteplase is usually administered at your doctor's office, hospital, or clinic. If you are using Alteplase at home, carefully follow the procedures taught to you by your health care provider.
• If Alteplase contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Mix Alteplase by swirling gently. Do not shake.
• Throw away any unused medicine left in the vial.
• Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when full.
• If you miss a dose of Alteplase , contact your doctor right away.

Ask your health care provider any questions you may have about how to use Alteplase .

Important safety information:

• Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Alteplase . Using Alteplase alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• Be sure you know why the catheter is not functioning before using Alteplase . If the catheter is not functioning due to a reason other than clotted blood, contact your doctor before using Alteplase .
• Contact your doctor if the catheter remains blocked after using this product as directed.
• If redness, swelling, or pain develops at the catheter site, contact your doctor immediately.
• Alteplase may reduce the number of cells in your blood that help your blood clot (platelets). To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.
• If serious bleeding occurs while you are using Alteplase , contact your doctor immediately.
• Additional monitoring of your dose or condition may be needed if you are taking warfarin or aspirin.
• Use Alteplase with caution in the ELDERLY because they may be more sensitive to its effects.
• PREGNANCY AND BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using this product during pregnancy. It is unknown if Alteplase is excreted in breast milk. If you are or will be breast-feeding while you are using Alteplase , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Alteplase :

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include unusual bleeding.

Store Alteplase in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Store away from heat, moisture, and light. Keep Alteplase , as well as syringes and needles, out of the reach of children and away from pets.

General information:

• If you have any questions about Alteplase , please talk with your doctor, pharmacist, or other health care provider.
• Alteplase is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Alteplase . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.